Principal Process Engineer - Upstream/Downstream

Amgen; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Amgen is seeking a Principal Process Engineer to join the Facilities & Engineering group in support of Upstream and Downstream drug substance operations at our Holly Springs site. You will lead equipment design, qualification, commissioning, and ongoing operations to ensure reliable manufacturing of biopharmaceutical products.

Ideal candidates have advanced degrees with 6–12 years in biopharma engineering, strong project leadership, and experience with GMP, QA, and cross-functional teams.

Qualifications

• PhD or MS in chemical/biomedical engineering or related field.
• Multiple pathways with 6–12+ years in biopharma or related industry.
• Experience in GMP regulatory environments and change control.
• Leadership or management experience required or strongly preferred.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead design, build, commissioning and qualification of new process equipment.
• Drive 24/7 operations readiness and engineering support for manufacturing.
• Perform risk assessments and implement CAPA for systems.
• Coordinate with QA, Manufacturing, and maintenance teams across sites.
• Develop and mentor junior engineers and manage projects end-to-end.
• Oversee validation runs and ensure on-time project delivery.

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Chromatography systems

Centrifugation equipment

Viral filtration skids

Autoclaves

CIP systems

Job description

Job Description

Join Amgen’s Mission of Serving Patients

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Principal Process Engineer - Upstream/Downstream

What You Will Do

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. You will lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems, optimize processes, and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

• Site design, construction, start-up, and operational readiness:
• Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams.
• Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items.
• Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements.
• Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed.
• Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.
• Site Operations:
• Provide system ownership for Upstream and/or Downstream Drug substance process equipment, areas, and systems providing end-to-end support for operations.
• Serve as a main point of contact for Process and equipment engineering function.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable.
• Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Develop master maintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.
• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.
• Provide mentorship and coaching to junior engineering peers when they encounter challenges and roadblocks, as appropriate.
• Demonstrate knowledge and understanding of how building and process automation systems interact with and impact process equipment and be able to effectively communicate automation issues and needs to support groups and to management.
• Effectively communicate the correct level of detail for process risks in a timely manner to support groups and leadership.
• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.
• Up to 10% domestic/international travel.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of engineering experience

OR

• Master’s degree and 4 years of engineering experience

OR

• Bachelor’s degree and 6 years of engineering experience

OR

• Associate’s degree and 10 years of engineering experience

Or

• High school diploma / GED and 12 years of engineering experience

And

• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering or related technical field..
• 8+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.
• Demonstrated people and/or project management and leadership experience.
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Upstream and Downstream purification equipment such as cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Experience with designing and operating equipment used in biopharmaceutical manufacturing.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Understanding of safety requirements working in a GMP Biopharmaceutical production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork.
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations.
• Ability for domestic/international travel.